New drugs

Some of the views expressed in the following notes on newly approved products should be regarded as tentative, as there may have been limited published data and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. As a result of fuller experience, initial comments may need to be modified. The Committee is prepared to do this. Before new drugs are prescribed, the Committee believes it is important that full information is obtained either from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Insulin glargine
(Aust Prescr 2004;27:50-1)

Lantus (Aventis Pharma)

100 IU/mL in 3 mL cartridges, and 5 mL and 10 mL vials

Approved indication: diabetes mellitus

Australian Medicines Handbook section 10.1.1

Insulin glargine is a recombinant insulin. Its chemical structure differs from human insulin by three amino acids. The molecule is completely soluble at pH4, but after injection it becomes less soluble. Microprecipitates form, and these allow a slow continuous release of insulin. These properties make a daily injection of insulin glargine suitable for providing a patient’s basal insulin requirements.

In clinical trials insulin glargine had similar effects to NPH human insulin, but in some studies fewer patients experienced symptomatic hypoglycaemia. These trials were relatively short, so the long-term effectiveness of insulin glargine is currently unknown.

Patients may find insulin glargine more painful to inject because of its acidity. It should not be mixed with other insulins.

An analysis by the National Institute for Clinical Excellence in the UK concluded that while insulin glargine is an option for type 1 diabetes, it is not recommended for routine use in people with type 2 diabetes who require insulin.1

Reference

1. National Institute for Clinical Excellence. Full guidance on the use of long-acting insulin analogues for the treatment of diabetes - insulin glargine. London: NICE; 2002. http://www.nice.org.uk/pdf/53_Insulin_analogues_full_guidance.pdf [cited 2004 Feb]


NEW FORMULATIONS

Azithromycin
(Aust Prescr 2004;27:50-1)

Zithromax IV (Pfizer)

500 mg powder for solution for infusion in 10 mL glass vial


NEW STRENGTHS

Lercanidipine
(Aust Prescr 2004;27:50-1)

Zanidip (Solvay) 20 mg tablets


Perindopril erbumine
(Aust Prescr 2004;27:50-1)

Coversyl (Servier) 8 mg tablets


NEW PROPRIETARY BRANDS

Influenza vaccine
(Aust Prescr 2004;27:50-1)

Fluad (Chiron Vaccines)

0.5 mL in pre-filled syringe


Leuprorelin acetate
(Aust Prescr 2004;27:50-1)

Eligard (Mayne Pharma)

7.5 mg, 22.5 mg and 30 mg single use injection kit


Methylphenidate
(Aust Prescr 2004;27:50-1)

Concerta (Janssen-Cilag)

18 mg, 36 mg and 54 mg extended-release tablets



The T-score ( ) is explained in 'New drugs: transparency', Vol 30 No 1, Aust Prescr 2007;30:26-7.

Content created: March - 2004